Clinical Trials - Adaptive

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Adaptive Designs for Clinical Trials

taught by Vidyadhar Phadke

Aim of Course:

This online course, "Adaptive Designs for Clinical Trials" will introduce the adaptive design theory and the hands-on techniques for planning, designing, monitoring, and analyzing adaptive trials. We will summarize the major statistical methods for adaptive trials with an emphasis on the relationships among them. You will learn different adaptive trial designs such as sample-size re-estimation, drop-loser, biomarker-adaptive design, and response-adaptive randomization designs through trial examples and the programming tools provided (SAS and R). Challenges of adaptive trial implementations will be discussed and recommendations are provided. Ultimately, the attendees are expected to walk away with the right knowledge, skill, and tools for designing and managing adaptive trials.

This course may be taken individually (one-off) or as part of a certificate program.

Course Program:

SESSION 1:

  • General Concept
  • Fundamental Theory
  • Group Sequential Design
  • Adaptive Interim Analysis in Clinical Trials

SESSION 2:

  • Adaptive Dose Finding Design
  • Enrichment Design for Target Clinical Trials

SESSION 3:

  • Two-Stage Adaptive Design
  • Sample size estimation/allocation

SESSION 4:

  • Protocol Amendments
  • Clinical Trial Simulation
  • Efficiency of Adaptive Design
  • Case Studies


HOMEWORK:

Homework in this course consists of short answer questions to test concepts, guided data analysis problems using software, and guided data modeling problems using software.

In addition to assigned readings, this course also has discussion tasks, an end of course data modeling prject, example sofware examples/codes, and supplemental readings available online.


Adaptive Designs for Clinical Trials

Who Should Take This Course:

Statisticians with responsibility for designing, analyzing and reporting clinical trials.

Level:

Intermediate/Advanced


Organization of the Course:

This course takes place online at the Institute for 4 weeks. During each course week, you participate at times of your own choosing - there are no set times when you must be online. Course participants will be given access to a private discussion board. In class discussions led by the instructor, you can post questions, seek clarification, and interact with your fellow students and the instructor.

At the beginning of each week, you receive the relevant material, in addition to answers to exercises from the previous session. During the week, you are expected to go over the course materials, work through exercises, and submit answers. Discussion among participants is encouraged. The instructor will provide answers and comments, and at the end of the week, you will receive individual feedback on your homework answers.

Time Requirement:
About 15 hours per week, at times of  your choosing.

This course has supplemental reading that are available online, software examples, an end of course data modeling project, and discussion based tasks.

Credit:
Students come to the Institute for a variety of reasons. As you begin the course, you will be asked to specify your category:

  1. You may be interested only in learning the material presented, and not be concerned with grades or a record of completion.
  2. You may be enrolled in PASS (Programs in Analytics and Statistical Studies) that requires demonstration of proficiency in the subject, in which case your work will be assessed for a grade.
  3. You may require a "Record of Course Completion," along with professional development credit in the form of Continuing Education Units (CEU's).  For those successfully completing the course,  CEU's and a record of course completion will be issued by The Institute, upon request.


Course Text:

The following texts will be used during the course:

Pong, A.P. and Chow, S.C. (2010). Handbook of Adaptive Designs in Pharmaceutical and Clinical Development. Chapman and Hall/CRC, Taylor & Franics, New York, New York. 

FDA Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologics, The U.S. Food and Drug Administration, Rockville, Maryland, February, 2010, which can be downloaded here.

Software:

Students will have access to EaSt software, which implements some of statistical methods for the adaptive clinical trial designs described in the text book.  Illustrations and demos will be provided for students to work through on their own.


Adaptive Designs for Clinical Trials

Instructor(s):
Dates:
March 10, 2017 to April 07, 2017March 09, 2018 to April 06, 2018

Course Fee: $589